MAUDE Adverse Event Report: LARES RESEARCH LARES RESEARCH; HIGH-SPEED DENTAL HANDPIECE

Model Number 557

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event Description

Dr.Had a bur fall out of the handpiece while working on a patient.The patient did not swallow the bur and and was not injured.

• Brand Name: LARES RESEARCH
• Type of Device: HIGH-SPEED DENTAL HANDPIECE
• Manufacturer (Section D): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer (Section G): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer Contact: bruce holderbein ; 295 lockheed avenue; chico, CA 95973 ; 5303451767
• MDR Report Key: 15142724
• MDR Text Key: 304176716
• Report Number: 2916440-2022-00007
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 557
• Device Catalogue Number: 13130-222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1